Medical Device Establishment License (MDEL)

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Regulatory Editor

Published by regulatory affairs team in PharmaKnowl, Riyadh office.

In recent years, the medical device market in Saudi Arabia has experienced vigorous growth, underscoring the need for robust regulatory frameworks to ensure safety and efficacy. The Medical Device Establishment License (MDEL) is part of a regulatory landscape governed by the Saudi Food and Drug Authority (SFDA).

This article focuses exclusively on the MDEL stage. It offers a structured overview of the SFDA’s current requirements for obtaining and maintaining an establishment license, including eligibility classifications, documentation expectations, and post-licensing responsibilities.

What is the Medical Device Establishment License (MDEL)?

The Medical Device Establishment License MDEL is a compulsory license that permits local companies to import, distribute, or manufacture medical devices in Saudi Arabia.

Who Needs It and Role of SFDA?

An importer, distributor, or local manufacturer must secure the MDEL to conduct business within the Kingdom. For example, a local company cannot import or register a medical device (MDMA) without having the MDEL license.

The SFDA shall review, issue, and continuously supervise this license through its inspection and stringent regulatory control over the supply chain to ensure accountability for public health protection.

MDEL vs MDMA: Key Differences

Purpose	MDEL	MDMA
Issued For	Medical Device Company	Medical Device Product
Regulates	The entity handling medical devices	The product to be placed on the Saudi market
Who Needs It	Importers, Distributors, Warehouses, manufacturers, and Authorised Representatives	Legal Manufacturer holding the product’s licenses
Required For Market Access?	Yes	Yes
Validity Period	1 year	3 years
Linked to Device Risk Classification?	No	Yes, Classes A to D affect the documentation burden

MDEL Requirements

Firstly, all companies must obtain a commercial record (CR) for their establishments, as per the accepted commercial and economic activities listed by the SFDA. This is the first requirement before starting the MDEL process on the SFDA portal.

To prove compliance, establishments also need to have:

Quality management system (QMS)
Valid ISO 13485 certificate
Each type of establishment has specific requirements under the MDEL framework:

A. Local Manufacturers

Must hold a valid Saudi industrial license
Must appoint a full-time Technical Manager and Quality Manager
Supervise product development, risk control, and manufacturing.
Local manufacturers should adhere to the requirements for marketing medical devices.

B. Authorised Representatives (ARs)

The authorised representative (AR) can represent legal manufacturers, serving the SFDA liaison for all regulatory activities.
The AR must ensure post-marketing surveillance (PMS) compliance, as defined in the AR agreement, which outlines the duration and transfer of obligations.

C. Importers and Distributors

Maintain full supply, distribution, and storage records
Ensure traceability and submit Declaration of Conformity
Need to obtain a warehouse or an external warehouse renting agreement
Set SOPs for storage, transport, and tracking
Keep updated records and submit a compliance pledge

D. Warehousing Facilities

Appoint a full-time technical manager (biomedical or related field)
Comply with SFDA storage and transport rules
Obtain third-party licensing for rented or shared warehouses
Maintain inventory systems that support traceability and segregation
Pledge not to store any non-compliant devices

E. Service-Based Entities

This includes:

Medical Device Maintenance Providers
Testing Laboratories
Clinical Trial Verification Centres
Conformity Assessment Bodies
Radiation QA Providers
Technical Consultants

Each must meet their respective SFDA technical, operational, and reporting requirements.

Inspections and Audits

The SFDA may carry out pre-licensing inspections to confirm the establishments’ readiness, including the implementation of QMS, documentation, and operational setup, before issuing an MDEL.
SFDA will regularly conduct unannounced audits of establishments to ensure continuous compliance. These audits typically review:
- The storage, distribution, and traceability practices͏
- Licenses and documentation validity͏
- Adverse event reporting and recall readiness͏
- ISO-compliant QMS maintenance
Non-compliance can result in a warning, suspension, or even revocation of the license. Regular internal audit practice keeps the establishment alert and ready for inspection.

MDEL Fees, Renewal, and Amendments

The SFDA issues the Medical Device Establishment License (MDEL) in Saudi Arabia for one year. It should be renewed yearly by updating documents and paying fees through the SFDA portal. To learn the cost implications based on the type of establishment, see our SFDA Fees Guide, which details current licensing fees.